Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Lung Cancer

Treatments: Genetic: gene expression analysis; Genetic: protein expression analysis; Other: laboratory biomarker analysis; Other: biologic sample preservation procedure; Genetic: microarray analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897117

VU-VICC-THO-0136 (Other Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

P50CA090949 (U.S. NIH Grant/Contract)

VICC THO 0136

Details and patient eligibility

About

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.

Full description

OBJECTIVES:

• Develop statistical and computational methods for modeling the relationships between multiple variable protein and RNA expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches.
• Determine protein and RNA expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy.
• Correlate protein and RNA expression fingerprints with T-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival.

OUTLINE: This is a multicenter study.

Any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. Tissue are analyzed for molecular features that predict biologic behavior. Quantitation of RNA, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis.

Medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. Further progress in cancer treatment and tumor behavior after surgery are followed via record review.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Diagnosis of non-small cell lung cancer

  • Clinical stage I and II disease
  • Resectable disease and complete surgical resection planned

• Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network

• Tumor specimen samples must be available at resection

Exclusion criteria

• Chemotherapy before surgery
• Radiotherapy before surgery

Trial design

4,000 participants in 1 patient group

Resectable non-small cell lung cancer

Description:

Patients with clinical stage I or II invasive lung cancer that can be completely removed by surgery and who have not undergone chemotherapy or radiotherapy before surgery

Treatment:

Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Other: biologic sample preservation procedure

Genetic: microarray analysis

Other: laboratory biomarker analysis

Genetic: protein expression analysis

Genetic: gene expression analysis